Musi wa20 Nyamavhuvhu 2025, Abbisko Therapeutics yakazivisa kuti Center forDrug Evaluation (CDE) yeChina National Medical Products Administration (NlPA) yakabvumidza chikumbiro cheLND cheAbbisko's investigative oral PD-1 inhibitor, ABSK043, pamwe chete neShanghai Alist Pharmaceuticals KRAS G12C inhibitor, glecirasib, yekurapa varwere veNscLc vane KRAS G12C mutation.
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
Nhamba yefoni: 4008803716
Nhamba yeWeChat: 17801183037
Email：myimmnet@163.com
Nezve ABSK043
ABSK043 imhando itsva, inowanikwa nemuromo, inosarudza zvakanyanya mamorekuru madiki ePD-L1 inhibitor, iri yeAbbisko Therapeutics. Masero egomarara anogona kushandisa nzvimbo dzekudzivirira dziviriro dzakadai sePD-1 nePD-L1 yayo kuti asaonekwe uye asaburitswe, nokudaro achidzvinyirira kana kuderedza mhinduro dzemasero eI, ABSK043 inosunga zvakananga kune PD-L1 receptor uye inokonzera kupinda kwayo kubva mumasero, ichidzivirira PD-1/PD-L1 kusangana uye ichideredza kudzvinyirirwa kweT-cell nePD-L1. Mumamodeli epamberi pekiriniki, ABSK043 yakaratidza kushanda kwekudzivirira gomarara kwakafanana nemasoja ePD-L1 akatenderwa. Kunyange hazvo ma antibodies akawanda ePD-1/PD-L1 monoconal akatenderwa nedoro pasi rose, parizvino hapana mamorekuru madiki ePD-1/PD-L1 anotenderwa nemuromo, ABSK043 iri kuongororwa mukuyedzwa kuri kuitwa kwePhase 1 clinical yezvirwere zvakasimba zvakakwira muAustralia neChina.
Muchidzidzo chechikamu chekutanga (NCT04964375), ABSK043, mushonga wePD-L1 unodzivirira masero madiki, une simba, wakaratidza kushanda zvakanaka kwekutanga.
Maitiro
Mapoka ane bundu rakasimba rakakwira akapihwa mapiritsi eABSK043 anotangira pa200 mg kamwe chete pazuva (QD) kusvika pa1000 mg kaviri pazuva (BID), kuti vaongorore kuchengetedzeka kwavo uye kushanda kwavo kwekutanga. Uyezve, vakaongorora zviratidzo zve pharmacodynamic (PD), zvakaita sekushanda kwemasero eT uye PD-L1 pamusoro.
Mhedzisiro
Kubva pazuva rekupedzisira (Chikumi 7, 2024), varwere 77 vakanyoreswa uye vakarapwa. 87.0% yevarwere vakasangana nezviitiko zvisina kunaka zvekurapa (TEAEs), uye 29.9% vaive ≥ Giredhi 3. MaTEAE ≥15% aive anemia (22.1%). Hapana peripheral neuropathy yakataurwa. Mukushanda kwese kwemishonga yemapoka edosi anoshanda mumishonga (600 mg BID, 800 mg BID, uye 1000 mg BID), ORR ye24% (8/34) muvarwere vasina ICI yakaonekwa. Muvarwere 10 vasina ICI vane kenza yemapapu (9 vasati varapwa uye 1 vasina kurapwa), ORR yaive 40% (4/10). Zvinonyanya kukosha, 3 pa6 (50%) EGFR-muted uye 1 pa2 (50%) KRAS-muted pts yakawana chikamu chemhinduro (PR). Vese vatatu vakapindura neEGFR mutations vaive nePD-L1 TPS ≥ 50% uye vakaenderera mberi mushure mekurapwa kweEGFR TKI therapy kanenge kamwe chete, kusanganisira chizvarwa chechitatu. Mamwe mapinduriro akaitika mumhando shanu dzemabundu akasiyana: MSI-H/dMMR gastric cancer, MSI-H/dMMR endometrial adenocarcinoma, vaginal squamous cell carcinoma, breast cancer (Lynch syndrome), uye melanoma. Nguva yakareba yekupindura muchidzidzo ichi yaive mwedzi gumi nemanomwe (endometrial adenocarcinoma) uye pt ichiri kurapwa. Kushanda kweT cell uye kudzikira kwePD-L1 surface mushure mekurapwa kweABSK043 kwakaonekwa mumapoka ese eBID dose.
Nezve Glecirasib
Glecirasib (AST-24081) mushonga unodzivirira chirwere cheKRAS G12C. Miedzo yakati wandei yekudzivirira chirwere ichi iri kuenderera mberi muChina, United States neEurope yevarwere vane bundu repamusoro rine KRAS G12C mutation. Izvi zvinosanganisira miedzo yekurapa pamwe chete neSHP2 inhibitor AST-24082in NSCLC uye miedzo yekurapa chete mukenza yepancreatic. Uyezve, chiratidzo chekenza yepancreatic chakapihwa zita remushonga wenhaka muUnited States uye zita rekurapa kwechirwere ichi muChina. Muna Chivabvu 2025, Glecirasib yakatenderwa kutanga kumusika neChinaNMPA.
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
Nhamba yefoni: 4008803716
Nhamba yeWeChat: 17801183037
Email：myimmnet@163.com
Nguva yekutumira: Nyamavhuvhu-21-2025